Regulatory Affairs Officer
- Experience Level
- Experienced (non-manager)
BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations into different countries, with a presence in the UK, USA and Germany.
We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service. Our culture is one of openness, honesty and respect and our goal is to become the Global Leader in the Clinical Trails Supply Industry, known for our innovation, expertise, ethics and dedication to providing excellent customer services.
We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, without them we will not be able to deliver on our promises. Our future is exciting, come join us!
BAP have an amazing opportunity for a Regulatory Affairs to join our busy and growing team.
The Regulatory Affairs Officer will support the Regulatory Affairs and Pharmacovigilance manager with all associated BAP Pharma regulatory activities. The role will also contribute to the implementation, leading of projects and building of expertise within the Unlicensed Medicines space.
- Support the Regulatory Affairs and Pharmacovigilance Manager with day to day regulatory responsibilities and build Regulatory Expertise and provide regular update’s
- Attend relevant team and client meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary.
- Ensuring team members understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities
- Facilitate cross-functional awareness and understanding of regulatory issues.
- Providing Regulatory Advice and Information to meet Customer and colleague requests.
- Using knowledge of EU/national legislation, guidelines and regulatory environment to provide insightful responses to enquiries.
- Advise on matters of compliance, regulatory requirements and regulatory policy
- In partnership with operational hubs respond to Regulatory Authority queries and input to aggregate safety reports
- Respond to requests from authorities promptly and accurately
- Assist in populating and maintaining Regulatory Databases. Responsible for database entry and the document management of regulatory transactions undertaken at local level
- Participate in ad hoc and routine QC checking of regulatory data bases
- Obtain Authority Approvals for Supply of Unlicensed Medicines
- Obtain necessary approvals to import and supply unlicensed medicines for unmet patient needs
- Ensure implementation of Good Regulatory Practice (GRP) and Adhere to relevant procedures and practices to ensure GRP is maintained
- Maintenance of regulatory activities in line with company procedures.
- Life sciences or chemistry graduate to honours level or equivalent, Master’s degree preferred
- Previous experience in Regulatory Affairs (Human Medicinal Products) preferred
- Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) desirable
- Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
- Knowledge of the global unlicensed medicines market and or the Pharmaceutical industry is desirable
- Excellent communication skills with internal and external partners
- Analytical thinking and Ability to prioritise effectively
- Results focused with attention to detail
- Ability to multitask with excellent written and verbal communication skills
- Able to work on own and make decisions independently, where needed
This role reports to the Global Medicines Access Director. Overtime may be required from time to time to meet project deadlines. We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.